Sensor inserter having introducer

ABSTRACT

Methods, device and system for providing a sensor insertion assembly including an inserter housing, an introducer including a body portion having a proximal end and a distal end and a shaft portion comprising a channel and a distal end, the shaft portion extending downwardly from an edge of the body portion, the shaft portion including a holding member disposed along a length of the channel, the holding member configured to substantially releasably retain a sensor, an on-body electronics unit, wherein the introducer is configured for insertion of the sensor through an aperture in the on-body electronics unit prior to insertion through skin and a drive mechanism included in the inserter housing and operatively coupled to the introducer, wherein the drive mechanism drives the introducer and retained sensor through the skin are provided.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/040,674 filed Sep. 28, 2013, which is a continuation-in-partof U.S. patent application Ser. No. 12/893,974 filed Sep. 29, 2010, nowabandoned, which claims priority to U.S. Provisional Application No.61/246,825 filed Sep. 29, 2009, the disclosures of each of which areincorporated herein by reference for all purposes. The presentapplication is also a continuation-in-part of U.S. patent applicationSer. No. 12/795,634 filed Jun. 7, 2010, now U.S. Pat. No. 8,602,991,which is a continuation of U.S. patent application Ser. No. 11/216,932filed Aug. 30, 2005, now U.S. Pat. No. 7,731,657, the disclosures ofeach of which are incorporated herein by reference for all purposes. Thepresent application is also a continuation-in-part of U.S. patentapplication Ser. No. 13/022,616 filed Feb. 7, 2011, which is acontinuation of U.S. patent application Ser. No. 11/240,257 filed Sep.30, 2005, now U.S. Pat. No. 7,883,464, the disclosures of each of whichare incorporated herein by reference for all purposes. The presentapplication is also a continuation-in-part of U.S. patent applicationSer. No. 11/552,065 filed Oct. 23, 2006, now U.S. Pat. No. 9,259,175,the disclosure of which is incorporated herein by reference for allpurposes. The present application is also a continuation-in-part of U.S.patent application Ser. No. 12/129,573 filed May 29, 2008, now U.S. Pat.No. 8,613,703, which claims priority to U.S. Provisional Application No.60/941,060 filed May 31, 2007, the disclosures of each of which areincorporated herein by reference for all purposes. The presentapplication is also a continuation-in-part of U.S. patent applicationSer. No. 12/870,818 filed Aug. 28, 2010, now abandoned, which claimspriority to U.S. Provisional Application No. 61/238,159 filed Aug. 29,2009, the disclosures of each of which are incorporated herein byreference for all purposes. The present application is also acontinuation-in-part of U.S. patent application Ser. No. 12/873,301filed Aug. 31, 2010, now abandoned, which claims priority to U.S.Provisional Application No. 61/238,494 filed Aug. 31, 2009, thedisclosures of each of which are incorporated herein by reference forall purposes. The present application is also a continuation-in-part ofU.S. patent application Ser. No. 12/873,302 filed Aug. 31, 2010, nowabandoned, which claims priority to U.S. Provisional Application Nos.61/238,537 filed Aug. 31, 2009 and 61/238,483 filed Aug. 31, 2009, thedisclosures of each of which are incorporated herein by reference forall purposes. The present application is also a continuation-in-part ofU.S. patent application Ser. No. 13/171,401 filed Jun. 28, 2011, nowU.S. Pat. No. 9,572,534, which claims priority to U.S. ProvisionalApplication No. 61/359,816 filed Jun. 29, 2010, the disclosures of eachof which are incorporated herein by reference for all purposes. Thepresent application is also a continuation-in-part of U.S. patentapplication Ser. No. 13/434,804 filed Mar. 29, 2012, now U.S. Pat. No.9,743,862, which claims priority to U.S. Provisional Application No.61/470,454 filed Mar. 31, 2011, the disclosures of each of which areincorporated herein by reference for all purposes. The presentapplication is also a continuation-in-part of U.S. patent applicationSer. No. 11/026,766 filed Dec. 29, 2004, now abandoned, the disclosureof which is incorporated herein by reference for all purposes. Thepresent application is also a continuation-in-part of U.S. patentapplication Ser. No. 13/252,118 filed Oct. 3, 2011, now U.S. Pat. No.9,364,149, which is a continuation of U.S. patent application Ser. No.11/365,334 filed Feb. 28, 2006, now U.S. Pat. No. 8,029,441, thedisclosures of each of which are incorporated herein by reference forall purposes. The present application is also a continuation-in-part ofU.S. patent application Ser. No. 13/970,397 filed Aug. 19, 2013, nowU.S. Pat. No. 9,480,421, which is a continuation of U.S. patentapplication Ser. No. 11/240,259 filed Sep. 30, 2005, now U.S. Pat. No.8,512,243, the disclosures of each of which are incorporated herein byreference for all purposes. The present application is also acontinuation-in-part of U.S. patent application Ser. No. 11/530,473filed Sep. 10, 2006, now U.S. Pat. No. 9,398,882, which is acontinuation-in-part of U.S. patent application Ser. No. 11/240,259filed Sep. 30, 2005, now U.S. Pat. No. 8,512,243, the disclosures ofeach of which are incorporated herein by reference for all purposes. Thepresent application is also a continuation-in-part of U.S. patentapplication Ser. No. 11/380,883 filed Apr. 28, 2006, now abandoned, thedisclosure of which is incorporated herein by reference for allpurposes. The present application is also a continuation-in-part of U.S.patent application Ser. No. 13/717,501 filed Dec. 17, 2012, now U.S.Pat. No. 8,862,198, which is a continuation of U.S. patent applicationSer. No. 11/530,472 filed Sep. 10, 2006, now U.S. Pat. No. 8,333,714,the disclosures of each of which are incorporated herein by referencefor all purposes. The present application is also a continuation-in-partof U.S. patent application Ser. No. 11/192,773 filed Jul. 29, 2005, nowabandoned, the disclosure of which is incorporated herein by referencefor all purposes. The present application is also a continuation-in-partof U.S. patent application Ser. No. 11/552,072 filed Oct. 23, 2006, nowU.S. Pat. No. 9,788,771, the disclosure of which is incorporated hereinby reference for all purposes. The present application is also acontinuation-in-part of U.S. patent application Ser. No. 11/027,230filed Dec. 29, 2004, now U.S. Pat. No. 8,571,624, the disclosure ofwhich is incorporated herein by reference for all purposes. The presentapplication is also a continuation-in-part of U.S. patent applicationSer. No. 12/895,015 filed Sep. 30, 2010, now U.S. Pat. No. 9,351,669,which claims priority to U.S. Provisional Application No. 61/247,516filed Sep. 30, 2009, the disclosures of each of which are incorporatedherein by reference for all purposes. The present application is also acontinuation-in-part of U.S. patent application Ser. No. 11/617,698filed Dec. 28, 2006, now U.S. Pat. No. 8,545,403, which claims priorityto U.S. Provisional Application No. 60/754,870 filed Dec. 28, 2005, thedisclosures of each of which are incorporated herein by reference forall purposes. The present application is also a continuation-in-part ofU.S. patent application Ser. No. 12/571,349 filed Sep. 30, 2009, nowU.S. Pat. No. 8,852,101, which is a continuation of U.S. patentapplication Ser. No. 11/535,983 filed Sep. 28, 2006, now U.S. Pat. No.7,697,967, which claims priority to U.S. Provisional Application No.60/754,870 filed Dec. 28, 2005, the disclosures of each of which areincorporated herein by reference for all purposes. The presentapplication is also a continuation-in-part of U.S. patent applicationSer. No. 12/032,593 filed Feb. 15, 2008, now U.S. Pat. No. 9,636,450,which claims priority to U.S. Provisional Application No. 60/890,497filed Feb. 19, 2007, the disclosures of each of which are incorporatedherein by reference for all purposes.

FIELD OF THE DISCLOSURE

The present disclosure relates to a sensor delivery unit. Moreparticularly, the present disclosure relates to a sensor inserter havinga safety member to impede actuation of the inserter. The presentdisclosure also relates to an introducer having a holding memberconfigured to releasably retain a sensor, such as an analyte sensor. Theintroducer can further comprise a compressible member configured to tentthe skin and puncture the skin to a reduced depth during insertion of asensor. The present disclosure also relates to a method of arming thesensor delivery unit.

BACKGROUND

Diabetes Mellitus is an incurable chronic disease in which the body doesnot produce or properly utilize insulin. Insulin is a hormone producedby the pancreas that regulates blood sugar (glucose). In particular,when blood sugar levels rise, e.g., after a meal, insulin lowers theblood sugar levels by facilitating blood glucose to move from the bloodinto the body cells. Thus, when the pancreas does not produce sufficientinsulin (a condition known as Type I Diabetes) or does not properlyutilize insulin (a condition known as Type II Diabetes), the bloodglucose remains in the blood resulting in hyperglycemia or abnormallyhigh blood sugar levels.

The vast and uncontrolled fluctuations in blood glucose levels in peoplesuffering from diabetes cause long-term, serious complications. Some ofthese complications include blindness, kidney failure, and nerve damage.Additionally, it is known that diabetes is a factor in acceleratingcardiovascular diseases such as atherosclerosis (hardening of thearteries), leading to stroke, coronary heart disease, and otherdiseases. Accordingly, one important and universal strategy in managingdiabetes is to control blood glucose levels.

The first step in managing blood glucose levels is testing andmonitoring blood glucose levels by using conventional techniques, suchas drawing blood samples, applying the blood to a test strip, anddetermining the blood glucose level using colorimetric, electrochemical,or photometric test meters. Another more recent technique for monitoringglucose levels is by using commercially available continuous glucosemonitoring systems.

In accordance with the monitoring of glucose levels, a sensor istypically subcutaneously or transcutaneously positioned under the skinof a user. In this regard, a sensor inserter assembly, which can bepreloaded with a sensor, is employed to insert the sensor through theskin of a user. A new sensor is generally implanted under the user'sskin every three to seven days. Thus, easy to use sensor inserterassemblies causing reduced trauma to the skin during use are desired.

SUMMARY

In certain embodiments, a sensor insertion assembly is provided thatincludes an inserter housing, an introducer including a body portionhaving a proximal end and a distal end and a shaft portion comprising achannel and a distal end, the shaft portion extending downwardly from anedge of the body portion, the shaft portion including a holding memberdisposed along a length of the channel, the holding member configured tosubstantially releasably retain a sensor, an on-body electronics unit,wherein the introducer is configured for insertion of the sensor throughan aperture in the on-body electronics unit prior to insertion throughskin and a drive mechanism included in the inserter housing andoperatively coupled to the introducer that drives the introducer andretained sensor through the skin.

In certain embodiments, the introducer holding member may include one ormore rolling members disposed along a length of the shaft portion, therolling members configured to contact and releasably retain the sensor.The introducer rolling members may be configured to rotate. The sensorretained by the shaft portion of the introducer may be displaced fromthe shaft portion upon rotation of the rolling members. The introducerrolling members may be disposed within the channel. The introducerrolling members may be disposed within a sidewall of the channel. Theintroducer shaft portion may include an aperture formed in the channel,and the sensor may include a flange extending from an edge of thesensor, the flange disposed in the aperture formed in the channel. Theaperture may include a section configured to be wider than the width ofa sensor flange such that the sensor may be displaced from the shaft.The introducer holding member may comprise a sponge material disposedalong the channel of the shaft portion, the sponge material configuredto provide a soft interference fit with a sensor disposed in the shaftportion.

In certain embodiments, the introducer shaft portion is substantiallyhollow. The introducer shaft portion may be configured to retain atleast a portion of the sensor substantially subcutaneously when theshaft portion is removed from a skin layer. The introducer distal endmay include a tapered end configured to pierce the skin layer and atleast a portion of the sensor may be substantially retained within theshaft portion while the tapered end is piercing through the skin layer.The sensor may be substantially contemporaneously transcutaneouslyintroduced through the skin layer when the tapered end of the shaftportion is transcutaneously introduced to the skin layer. In certainembodiments, the sensor includes an analyte sensor. The analyte sensormay be a glucose sensor. The introducer may be configured to positionthe analyte sensor in fluid contact with an analyte of a user.

In certain embodiments, the introducer may include a compressible memberhaving a distal end, the compressible member attached to a lateral sideof the introducer shaft portion, wherein the distal end of thecompressible member is distal to the distal end of the introducer shaftportion. The compressible member may be configured to retract to allowthe sharp to penetrate skin of a user.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of various aspects, features, and embodiments ofthe subject matter described herein is provided with reference to theaccompanying drawings, which are briefly described below. The drawingsare illustrative and are not necessarily drawn to scale, with somecomponents and features being exaggerated for clarity. The drawingsillustrate various aspects and features of the present subject matterand may illustrate one or more embodiment(s) or example(s) of thepresent subject matter in whole or in part.

FIG. 1 is a perspective view showing a sensor inserter and adhesivemount constructed in accordance with the disclosed subject matter;

FIG. 2 is a perspective view of the adhesive mount and sensor attachedto the user's skin in accordance with the disclosed subject matter;

FIG. 3 is a perspective view of the transmitter attached to the adhesivemount in accordance with the disclosed subject matter;

FIG. 4 is an exploded perspective view of the embodiment of FIG. 1;

FIG. 5 is a cross-sectional view of the inserter of FIG. 1;

FIG. 6 is a schematic depiction of an introducer and sensor inaccordance with the disclosed subject matter;

FIG. 7 is a is a schematic depiction of a shaft portion of theintroducer in accordance with the disclosed subject matter;

FIG. 8 is a perspective view of a shaft portions having one or moreholding member in accordance with the disclosed subject matter;

FIG. 9 is a sectional view of the shaft portion of FIG. 8 in accordancewith the disclosed subject matter;

FIG. 10 is a sectional view of a shaft portion having one or moreholding member in accordance with the disclosed subject matter;

FIG. 11 is a perspective view of the shaft portion of FIG. 10 inaccordance with the disclosed subject matter;

FIG. 12 is a perspective view of a shaft portion having one or moreholding members in accordance with the disclosed subject matter;

FIG. 13 is a sectional view of a shaft portion having one or moreholding members in accordance with the disclosed subject matter in afirst configuration;

FIG. 14 is a sectional view of a shaft portion having one or moreholding member in accordance with the disclosed subject matter in asecond configuration;

FIG. 15 is a sectional view of a shaft portion having one or moreholding member in accordance with the disclosed subject matter in asecond configuration;

FIG. 16 is a perspective view of the shaft portion of FIG. 15 inaccordance with the disclosed subject matter;

FIG. 17 is a perspective view of the shaft portion of FIG. 15 inaccordance with the disclosed subject matter;

FIGS. 18-20 are views of a shaft portion in accordance with thedisclosed subject matter;

FIG. 21 is a sectional view of a shaft portion having one or moreholding member in accordance with the disclosed subject matter in asecond configuration;

FIG. 22 is a sectional view of a shaft portion having one or moreholding member in accordance with the disclosed subject matter in asecond configuration;

FIG. 23 is a side view of a shaft portion comprising a compressiblemember in accordance with the disclosed subject matter in a secondconfiguration;

FIG. 24 is an enlarged side view of a shaft portion of FIG. 23 inaccordance with the disclosed subject matter in a second configuration;

FIG. 25 is a partial side view of a shaft portion of FIG. 23 inaccordance with the disclosed subject matter in a second configuration;

FIG. 26 is a sectional view of a shaft portion of FIG. 23 in accordancewith the disclosed subject matter in a second configuration;

FIG. 27 is a side view of a shaft portion of FIG. 23 in accordance withthe disclosed subject matter in a second configuration;

FIG. 28-30 are schematic depictions of the introducer of FIGS. 23-27depressing the skin and retracting to allow introducer sharp to piercethe skin in accordance with the disclosed subject matter;

FIGS. 31-45 are perspective views of some embodiments of the safetymember of the sensor inserter assembly in accordance with the disclosedsubject matter;

FIG. 46 is a cross-sectional view of an inserter having a pin disposedagainst the shuttle of the inserter in accordance with the disclosedsubject matter; and

FIGS. 47-49 illustrate a method of arming a sensor.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

A detailed description of the disclosure is provided herein. It shouldbe understood, in connection with the following description, that thesubject matter is not limited to particular embodiments described, asthe particular embodiments of the subject matter may of course vary. Itis also to be understood that the terminology used herein is for thepurpose of describing particular embodiments only, and is not intendedto be limiting, since the scope of the disclosed subject matter will belimited only by the appended claims.

Where a range of values is provided, it is understood that eachintervening value between the upper and lower limit of that range andany other stated or intervening value in that stated range, isencompassed within the disclosed subject matter. Every range stated isalso intended to specifically disclose each and every “sub-rang” of thestated range. That is, each and every range smaller than the outsiderange specified by the outside upper and outside lower limits given fora range, whose upper and lower limits are within the range from saidoutside lower limit to said outside upper limit (unless the contextclearly dictates otherwise), is also to be understood as encompassedwithin the disclosed subject matter, subject to any specificallyexcluded range or limit within the stated range. Where a range is statedby specifying one or both of an upper and lower limit, ranges excludingeither or both of those stated limits, or including one or both of them,are also encompassed within the disclosed subject matter, regardless ofwhether or not words such as “from”, “to”, “through”, or “including” areor are not used in describing the range.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosed subject matter belongs. Although anymethods and materials similar or equivalent to those described hereincan also be used in the practice or testing of the present disclosedsubject matter, this disclosure may specifically mention certainexemplary methods and materials.

All publications mentioned in this disclosure are, unless otherwisespecified, incorporated herein by reference in its entirety herein forall purposes, including without limitation to disclose and describe themethods and/or materials in connection with which the publications arecited.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present disclosedsubject matter is not entitled to antedate such publication by virtue ofprior disclosure. Further, the dates of publication provided may bedifferent from the actual publication dates, which may need to beindependently confirmed.

As used herein and in the appended claims, the singular forms “a”, “an”,and “the” include plural referents unless the context clearly dictatesotherwise.

Nothing contained in the Abstract or the Summary should be understood aslimiting the scope of the disclosure. The Abstract and the Summary areprovided for bibliographic and convenience purposes and due to theirformats and purposes should not be considered comprehensive.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentdisclosed subject matter. Any recited method can be carried out in theorder of events recited, or in any other order which is logicallypossible. Reference to a singular item, includes the possibility thatthere are plural of the same item present. When two or more items (forexample, elements or processes) are referenced by an alternative “or”,this indicates that either could be present separately or anycombination of them could be present together except where the presenceof one necessarily excludes the other or others.

Various exemplary embodiments of the analyte monitoring system andmethods of the present disclosure are described in further detail below.Although the present disclosure is described primarily with respect to aglucose monitoring system, each aspect of the present disclosure is notintended to be limited to the particular embodiment so described.Accordingly, it is to be understood that such description should not beconstrued to limit the scope of the present disclosure, and it is to beunderstood that the analyte monitoring system can be configured tomonitor a variety of analytes, as described below. Further, sectionheaders, where provided, are merely for the convenience of the readerand are not to be taken as limiting the scope of the present disclosurein any way, as it will be understood that certain elements and featuresof the present disclosure have more than one function and that aspectsof the present disclosure and particular elements are describedthroughout the specification.

A. Overview

The present disclosure is generally directed to an analyte monitoringsystem including an apparatus, such as an inserter, configured to insertvarious devices into the body of a subject, such as for example, ananalyte sensor, an infusion set, or a lancing device.

Certain classes of analyte monitoring systems are provided in small,lightweight, battery-powered and electronically-controlled systems. Suchsystems may be configured to detect signals indicative of in vivoanalyte levels using an electrochemical sensor, and collect suchsignals, with or without processing the signal. In some embodiments, theportion of the system that performs this initial processing may beconfigured to provide the raw or initially processed data to anotherunit for further collection and/or processing. Such provision of datamay be effected, for example, via a wired connection, such as anelectrical, or via a wireless connection, such as an IR or RFconnection.

Certain analyte monitoring systems for in vivo measurement employ asensor that measures analyte levels in interstitial fluids under thesurface of the subject's skin. These may be inserted partially throughthe skin or positioned entirely under the skin. A sensor in such asystem may operate as an electrochemical cell. Such a sensor may use anyof a variety of electrode configurations, such as a three-electrodeconfiguration (e.g., with “working”, “reference” and “counter”electrodes), driven by a controlled potential (potentiostat) analogcircuit, a two-electrode system configuration (e.g., with only workingand counter electrodes), which may be self-biasing and/or self-powered,and/or other configurations. In some embodiments, the sensor may bepositioned within a blood vessel.

In certain systems, the analyte sensor is in communication with a sensorcontrol unit. As used in this disclosure, an on-body unit sometimesrefers to such a combination of an analyte sensor with such a sensorcontrol unit. The analyte monitoring system may include an on-body unitincluding a sensor and a monitor unit. Exemplary embodiments ofcombination analyte sensor and sensor control unit configurations arefurther disclosed in, among others, U.S. patent application Ser. Nos.12/873,301 and 11/530,473, now U.S. Pat. No. 9,398,882, the disclosuresof each of which are incorporated herein by reference for all purposes.In some embodiments, the on-body unit includes electronics configured toprocess the signal generated by the sensor and may further include atransmitter, transceiver, or other communications electronics to providethe processed data to the monitor unit via a communication link betweenthe on-body unit and the monitor unit.

Analyte monitoring systems, in some embodiments, include an adhesivemounting unit for adhering the on-body unit to a patient's skin.Exemplary mounting units can be found in, among others, U.S. patentapplication Ser. Nos. 12/873,302, 13/171,401, now U.S. Pat. No.9,572,534, and Ser. No. 11/027,230, now U.S. Pat. No. 8,571,624, thedisclosures of each of which are incorporated herein by reference forall purposes. In certain embodiments, mounting units include a basemodule in addition to an adhesive. The base module may be configured tophysically couple with the on-body unit electronics for adhesivemounting of the on-body unit electronics to the patient. Examples ofsuch coupling embodiments can be found in, among others, Ser. No.12/895,015, now U.S. Pat. No. 9,351,669, and Ser. No. 11/365,334, nowU.S. Pat. No. 8,029,441, the disclosures of each of which areincorporated herein by reference for all purposes. In some embodimentsthe mounting unit may also include a temperature sensing module tomonitor the temperature of the skin of the patient, such as disclosed inSer. No. 11/026,766, the disclosure of which is incorporated herein byreference.

In certain embodiments, the on-body unit is placed on the skin of thepatient prior to insertion of the sensor through the skin. In suchembodiments, the sensor may be inserted through an aperture in theon-body unit prior to penetration of skin. Exemplary disclosures ofthese embodiments can be found in, among others, U.S. Publication Nos.2011/0213225, 2010/0198034, 2010/0324392, 2011/0319729, 2011/0288574,2012/0010642 and 2013/0150691, the disclosures of which are incorporatedherein by reference for all purposes.

The monitor unit can include a display for displaying or communicatinginformation to the user of the analyte monitoring system or the user'shealth care provider or another. The monitor unit is also referred to inthis disclosure as a “receiver unit” or “receiver device”, or in somecontexts, depending on the usage, as a “display unit,” “handheld unit,”or “meter”. In some embodiments, receiver may also include buttonsand/or scroll wheel which allow a user to interact with a user interfacelocated on receiver. The monitor unit, in some embodiments, may include,e.g., a mobile telephone device, a personal digital assistant, otherconsumer electronic device such as MP3 device, camera, radio, etc., orother communication-enabled data processing device.

The monitor unit may perform data processing and/or analysis, etc. onthe received analyte data to generate information pertaining to themonitored analyte levels. The monitor unit may incorporate a displayscreen, which can be used, for example, to display measured analytelevels, and/or audio component such as a speaker to audibly provideinformation to a user, and/or a vibration device to provide tactilefeedback to a user. It is also useful for a user of an analyte monitorto be able to see trend indications (including the magnitude anddirection of any ongoing trend), and such data may be displayed as well,either numerically, or by a visual indicator, such as an arrow that mayvary in visual attributes, such as size, shape, color, animation, ordirection. The receiver device may further incorporate an in vitroanalyte test strip port and related electronics in order to be able tomake discrete (e.g., blood glucose) measurements.

In certain embodiments described herein, on-body unit and monitor unitcommunicate via communications link (in this embodiment, a wireless RFconnection). Communication may occur, e.g., via RF communication,infrared communication, Bluetooth® communication, Zigbee® communication,802.1x communication, or WiFi communication, etc. In some embodiments,the communication may include an RF frequency of 433 MHz, 13.56 MHz, orthe like. In some embodiments, a secondary monitor unit may be provided.A data processing terminal may be provided for providing furtherprocessing or review of analyte data.

In certain embodiments, the analyte monitoring system may be acontinuous analyte monitor (e.g., a continuous glucose monitoring systemor CGM), and accordingly operate in a mode in which the communicationsvia communications link has sufficient range to support a flow of datafrom the on-body unit to the monitor unit. In some embodiments, the dataflow in a CGM system is automatically provided by the on-body unit tothe monitor unit. For example, in some embodiments no user interventionis required for the on-body unit to send the data to the monitor unit.In some embodiments, the on-body unit provides the signal relating toanalyte level to the receiving unit 300 on a periodic basis. Forexample, the signal may be provided, e.g., automatically sent, on afixed schedule, e.g., once every 250 ms, once a second, once a minute,etc. In some embodiments, the signal is provided to the monitor unitupon the occurrence of an event, e.g., a hyperglycemic event or ahypoglycemic event, etc. In some embodiments, on-body unit may furtherinclude local memory in which it may record “logged data” or buffereddata collected over a period of time and provide the some or all of theaccumulated data to monitor unit from time-to-time. A separate datalogging unit may be provided to acquire periodically received data fromon-body unit. Data transmission may be one-way communication, e.g., theon-body unit provides data to the monitor unit without receiving signalsfrom the monitor unit. In some embodiments, two-way communication isprovided between the on-body unit and the monitor unit.

In some embodiments, the analyte monitoring system includes a sensorwhich obtains an analyte signal which is provided to the monitor unit“on demand.” According to such embodiments, the monitor unit requests asignal from the on-body unit, or the on-body unit may be activated tosend signal upon activation to do so. Accordingly, one or both of theon-body unit and monitor unit may include a switch activatable by a useror activated upon some other action or event, the activation of whichcauses analyte-related signal to be transferred from the on-body unit tothe monitor unit. For example, the monitor unit is placed in closeproximity with a transmitter device and initiates a data transfer,either over a wired connection, or wirelessly by various means,including, for example various RF-carried encodings and protocols and IRlinks.

In some embodiments, the signal relating to analyte level isinstantaneously generated by the analyte sensor upon receipt of therequest, and provided to the monitor unit as requested, and/or thesignal relating to analyte level is periodically obtained, e.g., onceevery 250 ms, once a second, once a minute, etc. Upon receipt of the “ondemand” request at the on-body unit, an analyte signal is provided tothe monitor unit. In some cases, the signal provided to the monitor unitis or at least includes the most recent analyte signal(s).

In further embodiments, additional data is provided to the monitor unit“on demand.” For example, analyte trend data may be provided. Such trenddata may include two or more analyte data points to indicate thatanalyte levels are rising, falling, or stable. Analyte trend data mayinclude data from longer periods of time, such as, e.g., severalminutes, several hours, several days, or several weeks.

In some embodiments, analyte monitoring systems may further includemedication infusion devices integrated therewith. Examples of suchembodiments can be found in, among others, U.S. patent application Ser.No. 11/552,065, now U.S. Pat. No. 9,259,175, and Ser. No. 12/032,593,now U.S. Pat. No. 9,636,450, the disclosures of each of which areincorporated herein by reference for all purposes.

Further embodiments of analyte monitoring systems and on demand analytemonitoring system are further disclosed in U.S. Pat. No. 6,175,752 andU.S. Publication Nos. 2011/0213225, 2010/0198034, 2010/0324392,2011/0319729, 2011/0288574, 2012/0010642 and 2013/0150691, thedisclosures of each of which are incorporated herein by reference forall purposes. Further details regarding on demand systems are alsodisclosed in U.S. Pat. No. 7,620,438, U.S. Patent Publication Nos.2009/0054749, 2007/0149873, 2008/0064937, 2008/0071157, 2008/0071158,2009/0281406, 2008/0058625, 2009/0294277, 2008/0319295, 2008/0319296,2009/0257911, 2008/0179187, 2007/0149875, 2009/0018425, and U.S. patentapplication Ser. No. 12/625,524, now U.S. Pat. No. 8,390,455, Ser. No.12/625,525, now U.S. Pat. No. 8,358,210, Ser. No. 12/625,528, now U.S.Pat. No. 8,115,635, Ser. Nos. 12/628,201, 12/628,177, 12/628,198,12/628,203, 12/628,210, 12/393,921, 61/149,639, 12/495,709, 61/155,889,61/155,891, 61/155,893, 61/165,499, 61/227,967, 61/163,006, 12/495,730,12/495,712, now U.S. Pat. No. 8,437,827, 61/238,461, 61/256,925,61/238,494, 61/238,159, 61/238,483, 61/238,581, 61/247,508, 61/247,516,61/247,514, 61/247,519, 61/249,535, 12/544,061, 12/625,185, now U.S.Pat. No. 8,354,013, Ser. No. 12/625,208, now U.S. Pat. No. 9,042,954,Ser. Nos. 12/624,767, 12/242,780, now U.S. Pat. No. 8,983,568, Ser. Nos.12/183,602, 12/211,014, now U.S. Pat. No. 8,636,884, and Ser. No.12/114,359, now U.S. Pat. No. 8,080,385, the disclosures of each ofwhich are incorporated by reference in their entirety herein for allpurposes.

B. Sensor

The sensor, in accordance with one embodiment of the present disclosure,can be configured to detect and monitor an analyte of interest presentin a biological sample of a user. The biological sample can be abiological fluid containing the analyte of interest, such as (but notlimited to) interstitial fluid, blood, and urine. The analyte ofinterest can be one or more analytes including acetyl choline, amylase,bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g.,CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growthhormones, hormones, ketones, lactate, peroxide, prostate-specificantigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.However, other suitable analytes can also be monitored, as would beknown in the art. Furthermore, the analyte monitoring system can beconfigured to monitor the concentration of drugs, such as, for example,antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin,digoxin, theophylline, warfarin, and the like.

During use, the sensor is physically positioned in or on the body of auser whose analyte level is being monitored by an insertion device. Thesensor can be configured to continuously sample the analyte level of theuser and convert the sampled analyte level into a corresponding datasignal for transmission by the transmitter. In some embodiments, thesensor is implantable into a subject's body for a period of time (e.g.,three days, five days, seven days, etc.) to contact and monitor ananalyte present in the biological fluid. Thus, a new sensor must be usedtypically every three to seven days.

Generally, the sensor comprises a substrate, one or more electrodes, asensing layer and a barrier layer, as described below and disclosed inU.S. Pat. Nos. 6,284,478 and 6,990,366, the disclosures of which areincorporated by reference in their entirety herein for all purposes. Inone embodiment, the sensor includes a substrate. In some embodiments,the substrate is formed from a relatively flexible material. Suitablematerials for a flexible substrate include, for example, non-conductingplastic or polymeric materials and other non-conducting, flexible,deformable materials. Suitable plastic or polymeric materials includethermoplastics such as polycarbonates, polyesters (e.g., Mylar® andpolyethylene terephthalate (PET)), polyvinyl chloride (PVC),polyurethanes, polyethers, polyamides, polyimides, or copolymers ofthese thermoplastics, such as PETG (glycol-modified polyethyleneterephthalate). In other embodiments, the sensor includes a relativelyrigid substrate. Suitable examples of rigid materials that may be usedto form the substrate include poorly conducting ceramics, such asaluminum oxide and silicon dioxide. Further, the substrate can be formedfrom an insulating material. Suitable insulating materials includepolyurethane, Teflon (fluorinated polymers), polyethyleneterephthalate(PET, Dacron) or polyimide.

The substrate can include a distal end and a proximal end. In someembodiments, the distal and proximal ends have different widths. In someembodiments, the distal and proximal ends have the same width. In someembodiments, the proximal end of the sensor remains above the skinsurface. In such embodiments, the distal end of the substrate may have arelatively narrow width. Moreover, sensors intended to be positioned atleast partially into the tissue of a user's body at can be configured tohave narrow distal end or distal point to facilitate the insertion ofthe sensor. For example, for insertable sensors designed for continuousor periodic monitoring of the analyte during normal activities of thepatient, a distal end of the sensor which is to be implanted into theuser has a width of 2 mm or less, preferably 1 mm or less, and morepreferably 0.5 mm or less. In certain embodiments, as disclosed in U.S.patent application Ser. No. 12/870,818, the disclosure of which isincorporated herein by reference, the sensor substrate distal end isconstructed of material and shape to facilitate insertion of the distalend of the sensor through the skin of a patient without the use of anintroducer sharp.

A plurality of electrodes can be disposed near the distal end of sensor.The electrodes include working electrode, counter electrode andreference electrode. Other embodiments, however, can include a greateror fewer number of electrodes.

Each of the electrodes is formed from conductive material, for example,a non-corroding metal or carbon wire. Suitable conductive materialsinclude, for example, vitreous carbon, graphite, silver,silver-chloride, platinum, palladium, or gold. The conductive materialcan be applied to the substrate by various techniques including laserablation, printing, etching, silk-screening, and photolithography. Inone embodiment, each of the electrodes is formed from gold by a laserablation technique. The sensor can include conductive traces extendingfrom electrodes to corresponding, respective contacts to define thesensor electronic circuitry. In one embodiment, an insulating substrate(e.g., dielectric material) and electrodes are arranged in a stackedorientation (i.e., insulating substrate disposed between electrodes).Alternatively, the electrodes can be arranged in a side by sideorientation (not shown), as described in U.S. Pat. No. 6,175,752, thedisclosure of which is incorporated by reference in its entirety hereinfor all purposes.

The sensor can include a sensing material having one or more componentsdesigned to facilitate the electrolysis of the analyte of interest. Thecomponents, for example, may be immobilized on the working electrode.Alternatively, the components of the sensing layer may be immobilizedwithin or between one or more membranes or films disposed over theworking electrode or the components may be immobilized in a polymeric orsol-gel matrix. Further aspects of the sensor are described in U.S. Pat.Nos. 5,262,035, 5,264,104, 5,264,105, 5,320,725, 5,593,852, and5,665,222, each of which is incorporated by reference in its entiretyherein for all purposes.

In some embodiments, the sensor is a self-powered analyte sensor, whichis capable of spontaneously passing a currently directly proportional toanalyte concentration in the absence of an external power source. Anyexemplary sensor is described in U.S. patent application Ser. No.12/393,921, filed Feb. 26, 2009, which is hereby incorporated byreference in its entirety herein for all purposes.

C. Inserter

In one aspect of the present disclosure, an inserter is provided. Theobject to be inserted into the subject can be, for example, an analytesensor as described above. Alternatively, other objects such as but notlimited to an infusion set, or lancing device can be inserted.

An exemplary embodiment of the sensor inserter assembly 100 isillustrated in FIGS. 1-5. Generally, the sensor inserter assembly 100includes a sensor (not shown) preloaded within inserter 110. Afterpreparing an insertion site on the skin of a user, the user removes anupper liner 116 and lower liner 118 from an adhesive mount 112 to exposethe bottom surface and a portion of the top surface of an adhesive tapelocated on the bottom surface of the mount 112. Mount 112, with inserter110 attached, is then applied to the user's skin at the insertion site.The inserter includes an actuator button 124 to be pressed causinginserter 110 to fire, thereby inserting sensor 114 (not shown in FIG. 1)into the user's skin S. In some embodiments of the present disclosure,the inserter 110 includes a safety member to impede actuation of theinserter as described below. Mount 112, in certain embodiments, may beconfigured to receive inserter 110 in only a single configuration, thusensuring proper alignment of the inserter 110 on the mount. Exemplaryembodiments of mount and inserter configured for proper alignment can befound in, among others, U.S. patent application Ser. No. 11/380,883, andSer. No. 11/535,983, now U.S. Pat. No. 7,697,967, the disclosures ofeach of which are incorporated herein by reference for all purposes.

Once sensor 114 has been inserted into the skin S, the user removesinserter 110 from mount 112 by pressing release tabs 126 on oppositesides of inserter 110 and lifting inserter 110 away from mount 112.Further details of the inserter assembly 100 are provided in U.S. Pat.No. 7,381,184, which is incorporated by reference in its entirety hereinfor all purposes. In other embodiments, the inserter maybe integratedwith the mount, wherein after insertion of the sensor through the skinof the patient, the sensor electronics unit is slid into place on themount, while the inserter remains part of the mount. Exemplaryembodiments are disclosed in, among others, U.S. patent application Ser.No. 11/216,932, now U.S. Pat. No. 7,731,657, Ser. Nos. 11/192,773,11/240,257, now U.S. Pat. No. 7,883,464, Ser. No. 11/240,259, now U.S.Pat. No. 8,512,243, and Ser. No. 11/530,472, now U.S. Pat. No.8,333,714, the disclosures of each of which are incorporated herein byreference for all purposes.

Once inserter 110 is removed from mount 112, sensor electronics unit 130can be slid into place, as illustrated in FIG. 3. The circuitry ofsensor electronics unit 130 makes electrical contact with the contactson sensor 114 after sensor electronics unit 130 is fully seated on mount112. As discussed hereinabove, mount 112, together with sensor 114, andsensor electronics unit 130 comprises an on-body unit. In someembodiments, sensor electronics unit 130 may include communicationscircuitry, such as a transmitter, transceiver, or the like, forcommunicating with additional equipment. For example, onceinitialization and synchronization procedures are completed,electrochemical measurements from sensor 114 can be sent, e.g.,wirelessly from sensor electronics unit 130 to a monitor unit, such asportable receiver 132, as shown in FIG. 3. Sensor 114, mount 112 andsensor electronics unit 130 remain in place on the user for apredetermined period, currently envisioned to be several hours, toseveral days, e.g., about three days, about five days, about seven days,etc. After expiration of the lifetime of the sensor, these componentsare then removed so that sensor 114 and mount 112 can be properlydiscarded. The entire procedure above can then be repeated with a newinserter 110, sensor 114 and mount 112. In some embodiments, the sensorelectronics unit 130 and receiver 132 are durable and are reused.

Referring to FIG. 4, the inserter assembly 100 according to oneembodiment can be assembled as shown from the following components:e.g., housing 134, actuator button 124, drive spring 136, shuttle 138,introducer sharp 140, sensor 114, retraction spring 142, inserter base144, upper liner 116, mounting unit 112, adhesive tape 120, and lowerliner 118.

Sensor 114 has a main surface 146 slidably mounted between U-shapedrails 148 of introducer sharp 140. Introducer sharp 140 can be mountedto face 154 of shuttle 138, such as with adhesive, heat stake orultrasonic weld. U.S. patent application Ser. No. 11/216,932, now U.S.Pat. No. 7,731,657, Ser. No. 11/617,698, now U.S. Pat. No. 8,545,403,and Ser. No. 11/535,983, now U.S. Pat. No. 7,697,967, discloseadditional embodiments of sensor introducer sharps and insertiondevices, the disclosures of which is incorporated herein by reference.

In some embodiments, shuttle 138 can be slidably and non-rotatablyconstrained on base 144 by arcuate guides 160. The shuttle can begenerally formed by an outer ring 162 and an inner cup-shaped post 164connected by two bridges 166. Bridges 166 can be configured to slidebetween the two slots 168 formed between guides 160 and allow shuttle138 to travel along guides 160 without rotating. Retraction spring 142can be captivated at its outer circumference by guides 160, at itsbottom by the floor 170 (FIG. 5) of base 144, at its top by bridges 166,and at its inner circumference by the outer surface of shuttle post 164.Drive spring 136 is captivated at its bottom and outer circumference bythe inside surface of shuttle post 164, at its top by the ceiling 172(FIG. 5) inside actuator button 124, and at its inner circumference bystem 174 depending from ceiling 172.

When drive spring 136 is compressed between actuator button 124 andshuttle 138 it can urge shuttle 138 towards base 144. When retractionspring 142 is compressed between shuttle 138 and base 144, it urgesshuttle 138 towards actuator button 124.

In some embodiments, the actuator button 124 is slidably received withinhousing 134 from below and resides in opening 176 at the top of housing134 with limited longitudinal movement. Arms 178 on each side ofactuator button 124 can be configured to travel in channels 180 alongthe inside walls of housing 134, as best seen in FIG. 5. Longitudinalmovement of actuator button 124 can be limited in one direction by thebase 182 of arms 178 contacting the edge of opening 176 at the top ofhousing 134, and in the other direction by the distal ends 184 of arms178 contacting stops 186 in channels 180. Slots 188 are preferablyprovided in the top of housing 134 for ease of housing manufacture andso tools can be inserted to inwardly compress arms 178 beyond stops 186to allow actuator button 124 to be removed from housing 134 if needed.

When sensor 114, introducer 140, shuttle 138, retraction spring 142,drive spring 136 and actuator button 124 are assembled between base 144and housing 134 as shown in FIG. 5 and described above, housing 134 issnapped into place on base 144. Base 144 is held onto housing 134 byupper base barbs 190 that engage upper openings 192 in housing 134, andlower base barbs 194 that engage lower openings 192 in housing 134.

Generally, in accordance with one embodiment of the present disclosure,as illustrated in FIG. 6, an introducer 440 is provided which comprisesa body portion 401 and a shaft portion 405. Introducer 440 issubstantially identical to introducer 140, and useful with an inserter,such as inserter assembly 100 described hereinabove, with thedifferences illustrated in the accompanying figures, and describedherein. The shaft portion 405 can include a substantially sharp distaledge segment 403 to contact and pierce the skin of a user fortranscutaneous placement of the sensor through the user's skin S. Asshown, the sensor 114 is retained within the shaft portion 405 of theintroducer 440 and is configured to be held in position during insertionof the sensor through the user's skin by the substantially hollowcylindrical shape of the shaft portion 405, as illustrated in FIG. 6.

In some embodiments, referring to FIGS. 6 and 7, the tip of the analytesensor 114 can be retained at the distal edge segment 403 of theintroducer 440 during the subcutaneously or transcutaneous positioningof the sensor 114 through the user's skin. Thus, the sensor 114 ispositioned within the substantially hollow shaft portion 405 of theintroducer 440. The distal edge segment 403 of the introducer 440 isconfigured to first pierce through the user's skin, and guide sensorretained in the shaft portion 405 of the introducer 440 through thepierced skin of the user. After placement of the sensor 114 at thedesired location under the skin, the introducer 440 can be retractedfrom the user, leaving the sensor 114 in place. In some embodiments,during the introducer removal process, a radial configuration 404 of theshaft portion 405 is configured to guide the removal of the introducer440 from the pierced skin.

In some embodiments, the shaft portion includes one or more holdingmembers configured to retain the sensor in the introducer. For example,but not limitation, the shaft portion 405 of the introducer 440 may havea ribbed configuration to provide additional friction fit during theinsertion of the introducer and sensor through the skin of the user.

The holding member can include various configurations, as depicted inFIGS. 8 to 31. In one embodiment, as shown in FIGS. 8-9, the shaftportion 405 may include one or more rolling members 406. The rollingmembers 406 can include for example rollers, balls, or wheels. In someembodiments, the rolling members 406 are disposed within the channel orwall of the shaft portion 405. The rolling members 406 are configured toretain the sensor 114 in the introducer 140 by friction forces prior toinsertion of the sensor 114 into the user's body. During the insertionprocess, the rolling members 406 can turn or rotate to displace thesensor 114 from the introducer shaft 405 during the insertion process.When the sensor 114 is placed at the desired depth and caught in themount as part of the insertion (e.g., by hook, clamp or gripper), therolling members 406 rotate from the friction from the sensor 114 as theintroducer exits back into the inserter.

In some embodiments, as shown in FIGS. 10-11, the shaft portion 405 ofthe introducer 140 and the sensor 114 comprise a magnet 408 ormagnetized area 409, such that magnetic forces retain the sensor withinthe introducer. The magnetic material can be any material that willprovide magnetic forces including, but not limited to, low gradestainless steel, carbon ink, and the like. In some embodiments, theshaft or the sensor can be doped with magnetic metal. The magnet can bedisposed along the channel of the shaft portion. In this regard, inaccordance with one embodiment, magnetic material can be embedded on thesurface of the sensor. Further, a magnet or a magnetized area is fitinto the sharp to hold the sensor in place. Release of the magneticforce can occur when the shaft portion 405 is removed as part of theinsertion process of the sensor delivery unit.

In other embodiments, as illustrated in FIG. 12, the holding membercomprises a sheath 407 disposed coaxially about the shaft portion 405.The sheath 407 can comprise one or more perforations along a perforationline 410 disposed along a length of the sheath. In this manner, thesheath can be a tear away member. In some embodiments, the sheathcomprises a polymer film. The polymer film can be attached to an outersurface of the shaft portion. Suitable materials for the sheath includepolyimide, Pebax, polyethylene, Nylon, PTFE, polyester, andpolyurethane.

In another embodiment, as depicted in FIGS. 13-14, the shaft portion 405can include one or more windings 411 configured to releasably retain thesensor 114. The windings are generally a wound member 411 having thecapability to unwind, as illustrated in FIG. 14. While the winding 411is in the wound configuration, it applies an interference against thesensor body to retain the sensor 114. The sensor can be displaced fromthe shaft portion 405 upon unwinding the one or more windings. In someembodiments, the windings comprise wound rolls of polymer film.

In other embodiments, the shaft portion 405 of the introducer 140includes a substantially longitudinal opening 412, as shown in FIGS.15-17. The sensor 114 can include a flange 413 disposed along an edge ofthe sensor body 114 to communicate through the longitudinal opening 412.The engagement of the longitudinal opening 412 and the flange 413provide an interference fit to retain the sensor 114. In someembodiments, the slot includes a distal section 412B configured to bewider than the width of a proximal section 412A, and sufficiently widesuch that the sensor flange 413 may be displaced from the shaft when theflange becomes disposed in the wider section of the opening 412, forexample during the insertion process as the sensor travels towards aninsertion position. In this manner, the longitudinal opening 412 can beprovided with a greater width at a distal section to allow theintroducer 140 to be completely de-coupled from the sensor 114 retainedwithin the shaft portion 405 during the placement thereof, so that theintroducer 140 may be removed completely from the user, while leaving inplace the sensor 114.

As an alternative, illustrated in FIGS. 18-20 the sensor 114 can beconfigured to include a pin 415 extending from a lateral end of thesensor body. Similar to the flange member described above, the pin canengage a slot 412′ formed in the introducer so as to retain the sensorin the introducer. In some embodiments, the pin can be configured as ahinge member 416.

In yet another embodiment, the holding member can include a spongematerial 417 disposed along the channel of the shaft portion 405, asshown in FIG. 21. The sponge material 417 can be configured to provide asoft interference fit with a sensor 114 disposed in the shaft portion405 and may comprise polyurethane, polyether, polystyrene, or isoprenefoams. The foams can be attached via adhesive, or applied during thelubricious coating process (i.e., a silicone coating used to reducefriction and make insertion more smooth).

In other embodiments, the shaft 405 is provided with a diaphragm 418,such as a thin, semi-rigid membrane housed along a portion of thechannel. The diaphragm can include an opening 419 to receive and retainthe sensor, as shown in FIG. 22. The diaphragm 418 may be molded or castpolymer (silicone, urethane or TPE) plug or insert with a series ofslits or webbing similar to an iris. Or it could be a type of a duckbillvalve. In one embodiment, the diaphragm 418 is fixed (molded or glued)to the inner diameter of the introducer. The diaphragm 418 may be rigidenough to hold the sensor but flexible to open when the senor iscaptured during insertion.

In another aspect of the present disclosure, the introducer 440 may beconfigured to reduce the insertion and extraction forces through theuser's skin, thus reducing trauma to the skin. In this regard, theintroducer 440 can be configured to include a compressible member 518attached to a lateral side of the introducer 440, as illustrated inFIGS. 23-24. In some embodiments, the compressible member 518 caninclude a first section, or barrel 519, and a second section, or plunger520, as shown in FIG. 23. The first section 519 can include acompressible body. For example, the compressible body can include aspring, such as a compression spring 522 (illustrated in dashed lines).In some embodiments, the first section 519 includes a housing comprisingthe spring. The springs may be helical compression springs havingvariable pitch and compression rate. The shape of the spring can bestraight, hourglass, conical or barrel. Alternatively, a controlledfriction can be used to allow a plunger 520 to move inside the barrel519 at a set force. When the predetermined “break force” is reached, theplunger 520 can move. As illustrated in FIGS. 26-27, the shaft 405 ofthe introducer 440 is attached in some embodiments to the housing of thecompression member 518.

In some embodiments, the second section 520 of the compressible member518 is non-compressible, but retractable. For example, the secondsection 520 can be formed from a solid thermoplastic member. The firstsection 519 can be configured to receive the second section 520. In thismanner, the compressible member 518 can be compressed upon retraction ofthe second section 520 within the first portion housing 519. In thisregard, the first and second sections can have a telescopingrelationship, such that the sliding engagement of the second memberupwardly into the first member causes compression of the compressiblemember, as illustrated in FIG. 25. A first position of second section520 is illustrated in dashed line and the second position of the secondsection 520 is illustrated in solid line. The compression of thecompressible member 518 by the retraction of the second member 520causes the distal edge 403 of the introducer shaft, i.e., the sharp, tocontact and pierce through the skin of the user.

During operation, as shown in FIGS. 28-30, the compressible member 518contacts the skin S of a user. During this process, the second section520 of the compressible member contacts the skin S prior to theintroducer edge 403 because the distal end of the compressible member518 is initially distal to the introducer distal end 403. See FIGS.28-29. In this manner, the second member 520 can depress the skin S fromthe pressure of the contact between the second section 520 and the skinS. As shown in FIG. 30, the distal end 403 of the introducer 440 thenmakes contact with the skin S, as the compressible section 518compressed upon retraction of the second section 520 upwardly to allowthe distal end 403 of the introducer 440 to puncture the skin S andproceed to insert the sensor 114 (not shown in FIG. 30). Thecompressible member 518 allows control of the depth of the puncture. Bymaintaining a relatively small skin puncture, it is possible to reducethe amount of potential bleeding during the skin piercing process forsubcutaneous or transcutaneous sensor placement, and likewise the resultis less bruising and also faster healing.

In some embodiments, the edge segment 403 of the introducer 440 guidesthe sensor 114 into and through the skin puncture. The edge segment 403may be sharpened and polished to facilitate a smooth puncture and aclean cut through the user's skin. In this regard, the substantiallyhollow shaft portion can be configured to minimize the necessary forceto deploy the introducer, and minimize pain and skin trauma duringpuncture and removal of the introducer from the skin. In this regard,the edge segment 403 of the introducer 440 includes a substantiallysharp and angled tip (as shown in FIG. 6) for piercing the user's skin.The edge segment 403 of the introducer 440 can be sharp and tapered tofacilitate skin piercing while minimizing skin trauma. In this manner,it is possible to minimize the size of the skin wound at the piercingsite where the introducer 440 is placed through the skin, and thus, theuser will likely experience a faster healing time.

Referring to FIGS. 31-45, actuator 124 described hereinabove can beprovided with a safety member, such as safety member 625, 625′, 625″,634, 636, 650, configured to impede actuation of the actuator, by forexample, preventing the actuator button 124 from being depressed.Accordingly, the safety member can avoid accidental firing of inserterassembly 100. The safety member can take the form of variousconfigurations.

For example, the safety member 625 can comprise a pin or a plug member,such as, but not limited to, a “grenade” pin, or molded plug, asdisclosed in FIGS. 31-36. In this regard, as depicted in FIGS. 31-32,the actuator 124 can include one or more apertures or slots (not shown)extending through the actuator 124 through which the safety pin 628 isdisposed. The safety member can further include a pull tab 626 for easeof removal to deactivate the safety. As depicted in FIGS. 33-34, theactuator 124 can include one or more apertures or slots (not shown)extending through the actuator 124 through which the safety pin 628′ isdisposed. The safety member can further include a pull tab 626′ for easeof removal to deactivate the safety.

In yet another embodiment, the safety member 625″ can include a bodyhaving a first end 630 and a second end 632 configured to form anL-shaped body, as shown in FIGS. 35-36. In this regard, the L-shapedsafety member includes, as part of its unitary body a pull tab 630 thatprotrudes from the slot or aperture formed in actuator 124. In thismanner, the first or second ends of the L-shaped body can define a pulltab for deactivation of the safety.

In other embodiments, the safety member comprises a D-ring 634, as shownin FIGS. 37-38. The D ring 634 can be formed from plastic or a metal. Asillustrated in FIG. 39, the actuator can include a slot having anopening in communication with the exterior of the actuator. The D-ringcan be slid and disposed in the slot, as shown in FIG. 38.

In yet another embodiment, the safety member can comprise a press clip636, as illustrated in FIGS. 40-42. The press clip 636, in someembodiments, comprises first and second legs 638, 640 connected to eachother at a bridging member 642. The press clip 636 includes first andsecond feet 644, 646 configured to be disposed in one or more aperturesformed in the actuator, as illustrated in FIGS. 41 and 42. Theconfiguration of clip 636 provides an outward force, as indicated byarrows 40. The press clip 646 can be disposed in one or more aperturesformed on an interior surface of the actuator 124 as illustrated in FIG.42.

In yet another embodiment, the safety member can comprise a press clip650, as illustrated in FIGS. 43-45. The press clip 650, in someembodiments, comprises first and second legs 652, 654 connected to eachother at a bridging member 656. The press clip 650 includes first andsecond feet 658, 660 configured to be disposed in one or more aperturesformed in the actuator 124, as illustrated in FIGS. 44 and 45. Theconfiguration of clip 650 provides an inward force, as indicated byarrows 43. The press clip 650 can be disposed in one or more aperturesformed on an exterior surface of the actuator 124 as illustrated in FIG.45.

During disposition of the safety member 625 in the actuator, depressionof the actuator is impeded. The safety member can be formed from avariety of materials. For example, the material can be a thermoplasticmaterial, such as TPE materials or a metal. In some embodiments, thethermoplastic material has a shore hardness of about 40 to 50. Inanother embodiment, plastic, metal, wood, or paper can be formed in theshape of a pin as long as it could serve to prevent the downwardmovement of the button.

Upon deactivation of the safety member such as by removal of the safetymember, tabs 122, as illustrated in FIGS. 1 and 5, can be squeezedinward just enough to clear the rim 204 of opening 176 while pressingthe actuator button 124 down to fire the inserter. Alternatively, tabs122 can be squeezed further inward so that barbs on the inside edges canengage catches located on a center portion of actuator button 124 bysimply pressing down on the actuator button 124.

Referring back to FIG. 5, shuttle 138 is provided with laterallyextending barbed fingers 212 which travel in channels 180 along theinside walls of housing 134. When shuttle 138 is inserted up intohousing 134 far enough, barbed fingers 212 momentarily deflect inwardand then snap outward again to catch on stops 186. In this armed orcocked position as shown, drive spring 136 is compressed and urgingshuttle 138 towards base 144, but barbed fingers 212 catching on stops186 prevent such travel.

After manufacture of the sensor inserter assembly, the sensor inserterassembly can be shipped in an unarmed position. In this manner, nosafety member as described above is necessary for safe shipping orhandling as the sensor inserter assembly in its unarmed position cannotfire. In this regard, as shown in FIG. 46 the sensor inserter assembly110 in its unarmed position can include a pin 728 member, such as aplastic tubular member, disposed in the firing path of the inserter. Thepin 728 is configured to butt against the bottom of the shuttle 138 andprotrude from the bottom surface of the sensor inserter assembly, asshown in FIGS. 46 and 47. The pin 728 can keep the shuttle from bouncingon the return spring.

In another aspect of the present disclosure, a method is provided to armthe sensor inserter assembly. The sensor can be armed by the user priorto insertion of a sensor. The method includes, as shown in FIGS. 47-49,contacting the sensor inserter assembly against a surface, such as atable top. The contact of the pin 728 with a relatively hard surfacecauses the pin to be pushed upwardly the retraction position such thatthe barbed fingers 212 are moved to a cocked position, as describedabove. In this manner, the sensor inserter assembly can be configuredsuch that an audible click is sounded when the barbed fingers move toposition. During movement to the armed position, the actuator button 124moves upwardly to the cocked position. After the barbed fingers and theactuator are armed, the pin 728 is removed from the sensor insertionassembly and the sensor inserter assembly is armed and ready to use.

In operation, the user arms the drive mechanism, such as the firstspring, to generate the sufficient inertial force needed to drive theintroducer and the sensor through the user's skin. In one embodiment,the introducer and the sensor are provided in a fully assembled sensorinserter assembly package within a transmitter mounting unit. Thus, whenthe user wishes to place the sensor subcutaneously or transcutaneously,the drive mechanism is armed, and the user places the transmitter mounton the surface of the user's skin where the user wishes to place thesensor. In other embodiments, the sensor insertion assembly may beself-arming, allowing for ease of insertion of the sensor. Examples ofsuch embodiments can be found in, among others, U.S. patent applicationSer. No. 12/129,573, now U.S. Pat. No. 8,613,703, the disclosure ofwhich is incorporated herein by reference for all purposes.

Additional embodiments of analyte sensor insertion devices can be foundin, among others, U.S. patent application Ser. No. 11/552,072, now U.S.Pat. No. 9,788,771, Ser. No. 13/434,804, now U.S. Pat. No. 9,743,862,Ser. No. 11/216,932, now U.S. Pat. No. 7,731,657, Ser. No. 11/617,698,now U.S. Pat. No. 8,545,403, Ser. No. 11/380,883, and 11/535,983, nowU.S. Pat. No. 7,697,967, the disclosures of which are incorporatedherein by reference for all purposes. Such embodiments include insertiondevices utilizing variable speed insertion, by varying the speed of theshuttle through the insertion device; shape memory alloy insertiondevices, wherein the introducer is constructed of a shape memory alloythat changes shape from a compressed state to a rigid insertion shapeupon activation of the shape memory alloy; and coupleable insertiondevices and on-skin mounting units, wherein the systems are configuredsuch that the insertion device and on-skin mounting unit can only becoupled in a position such that the insertion device is aligned forproper sensor insertion.

Various other modifications and alterations in the structure and methodof operation of this present disclosure will be apparent to thoseskilled in the art without departing from the scope and spirit of thepresent disclosure. Although the present disclosure has been describedin connection with specific embodiments, it should be understood thatthe present disclosure as claimed should not be unduly limited to suchspecific embodiments. It is intended that the following claims definethe scope of the present disclosure and that structures and methodswithin the scope of these claims. Additional detailed description ofembodiments of the disclosed subject matter are provided in but notlimited to: U.S. Pat. Nos. 7,299,082; 7,167,818; 7,041,468; 6,942,518;6,893,545; 6,881,551; 6,773,671; 6,764,581; 6,749,740; 6,746,582;6,736,957; 6,730,200; 6,676,816; 6,618,934; 6,616,819; 6,600,997;6,592,745; 6,591,125; 6,560,471; 6,540,891; 6,514,718; 6,514,460;6,503,381; 6,461,496; 6,377,894; 6,338,790; 6,299,757; 6,284,478;6,270,455; 6,175,752; 6,161,095; 6,144,837; 6,143,164; 6,121,009;6,120,676; 6,071,391; 5,918,603; 5,899,855; 5,822,715; 5,820,551;5,628,890; 5,601,435; 5,593,852; 5,509,410; 5,320,715; 5,264,014;5,262,305; 5,262,035; 4,711,245; 4,545,382; 5,356,786; 5,543,326;6,103,033; 6,134,461; 6,143,164; 6,144,837; 6,161,095; 6,579,690;6,605,200; 6,605,201; 6,618,934; 6,654,625; 6,676,816; 6,730,200;6,736,957; and 6,932,892; and U.S. Publication Nos. 2004/0186365;2005/0182306; 2006/0025662; 2006/0091006; 2007/0056858; 2007/0068807;2007/0095661; 2007/0108048; 2007/0199818; 2007/0227911; 2007/0233013;2008/0066305; 2008/0081977; 2008/0102441; 2008/0148873; 2008/0161666;2008/0267823; and 2009/0054748; and U.S. patent application Ser. No.10/745,878, filed Dec. 26, 2003, now U.S. Pat. No. 7,811,231; U.S.patent application Ser. No. 12/143,731, filed Jun. 20, 2008, now U.S.Pat. No. 8,597,188; U.S. patent application Ser. No. 12/143,734, filedJun. 20, 2008, now U.S. Pat. No. 8,617,069; U.S. Provisional ApplicationNo. 61/149,639, filed Feb. 3, 2009; U.S. Provisional Application No.61/291,326 filed Dec. 30, 2009, and U.S. Provisional Application No.61/299,924 filed Jan. 29, 2010; U.S. patent application Ser. No.11/461,725, now U.S. Pat. No. 7,866,026; U.S. patent application Ser.No. 12/131,012; U.S. patent application Ser. No. 12/242,823, now U.S.Pat. No. 8,219,173; U.S. patent application Ser. No. 12/363,712, nowU.S. Pat. No. 8,346,335; U.S. patent application Ser. No. 12/698,124;U.S. patent application Ser. No. 12/698,129, now U.S. Pat. No.9,402,544; U.S. patent application Ser. No. 12/714,439; U.S. patentapplication Ser. No. 12/794,721, now U.S. Pat. No. 8,595,607; U.S.patent application Ser. No. 12/842,013, now U.S. Pat. No. 9,795,326;U.S. Provisional Application No. 61/238,646; U.S. ProvisionalApplication No. 61/345,562; U.S. Provisional Application No. 61/361,374;and elsewhere, the disclosures of each are incorporated by reference intheir entirety herein for all purposes.

The foregoing only illustrates the principles of the disclosed subjectmatter. Various modifications and alterations to the describedembodiments will be apparent to those skilled in the art in view of theteachings herein. It will be appreciated that those skilled in the artwill be able to devise numerous modifications which, although notexplicitly described herein, embody the principles of the disclosedsubject matter and are thus within the spirit and scope of the disclosedsubject matter.

The invention claimed is:
 1. A sensor insertion assembly, comprising: aninserter housing; an analyte sensor; a shuttle disposed within theinserter housing, the shuttle coupled to an introducer sharp, a drivespring, and a retraction spring, wherein the drive spring, upon release,is configured to displace the shuttle and the introducer sharp in adistal direction and to insert at least a portion of the analyte sensorin fluid contact with a bodily fluid under a skin layer, and wherein theretraction spring, upon release, is configured to displace the shuttleand the introducer sharp in a proximal direction; an actuator mechanismconfigured to release the drive spring; and a removable safety clipconfigured to impede actuation of the actuator mechanism, wherein theremovable safety clip comprises a first leg portion, a second legportion, and a bridging portion connecting the first and the second legportions, and wherein the first and the second leg portions are biasedin an inward direction.
 2. The sensor insertion assembly of claim 1,further comprising a mounting unit configured to releasably couple withthe inserter housing.
 3. The sensor insertion assembly of claim 2,wherein the mounting unit includes an aperture through which theintroducer sharp and the at least a portion of the analyte sensor arepositioned under a skin layer upon release of the drive spring.
 4. Thesensor insertion assembly of claim 2, wherein the mounting unit includesan adhesive bottom surface.
 5. The sensor insertion assembly of claim 2,wherein the mounting unit is configured to receive a sensor electronicsunit after the inserter housing is uncoupled from the mounting unit. 6.The sensor insertion assembly of claim 2, wherein the first leg portionincludes a first foot portion, wherein the second leg portion includes asecond foot portion, and wherein the first and the second foot portionsare configured to releasably engage one or more apertures on an exteriorsurface of the sensor insertion assembly.
 7. The sensor insertionassembly of claim 6, wherein the first and the second foot portions arebiased in an inward direction.
 8. The sensor insertion assembly of claim6, wherein the first and the second foot portions are configured todisengage from the one or more apertures upon application of one or moreforces to the first and the second leg portions.
 9. The sensor insertionassembly of claim 8, wherein the one or more forces comprises asqueezing force.
 10. The sensor insertion assembly of claim 1, whereinthe actuator mechanism comprises at least one depressible button. 11.The sensor insertion assembly of claim 10, wherein the removable safetyclip is further configured to prevent the at least one depressiblebutton from being depressed.
 12. The sensor insertion assembly of claim1, wherein the removable safety clip is further configured to disengagefrom the sensor insertion assembly upon application of one or moreforces to the first and the second leg portions.
 13. The sensorinsertion assembly of claim 1, wherein the at least a portion of theanalyte sensor is disposed in a channel of the introducer sharp whilethe drive spring is in a compressed state.
 14. The sensor insertionassembly of claim 1, wherein the drive spring and the retraction springcomprise compression springs.
 15. The sensor insertion assembly of claim1, wherein the drive spring and the retraction spring are each in acompressed state prior to the actuation of the actuator mechanism. 16.The sensor insertion assembly of claim 1, wherein the analyte sensor isa glucose sensor.
 17. The sensor insertion assembly of claim 1, whereinthe bridging portion comprises a flexible plastic material.
 18. Thesensor insertion assembly of claim 1, wherein a diameter of the drivespring is greater than a diameter of the retraction spring.
 19. Thesensor insertion assembly of claim 1, wherein the analyte sensorincludes a distal portion and a proximal portion, the distal portionconfigured to be in fluid contact with subcutaneous bodily fluid andhaving a width smaller than a width of the proximal portion.
 20. Asensor insertion assembly, comprising: an inserter housing; an analytesensor; a mounting unit configured to releasably couple with theinserter housing; a shuttle disposed within the inserter housing, theshuttle coupled to an introducer sharp, a drive spring, and a retractionspring, wherein the drive spring, upon release, is configured todisplace the shuttle and the introducer sharp in a distal direction andto insert at least a portion of the analyte sensor in fluid contact witha bodily fluid under a skin layer, and wherein the retraction spring,upon release, is configured to displace the shuttle and the introducersharp in a proximal direction; an actuator mechanism configured torelease the drive spring; and a removable safety clip configured toimpede actuation of the actuator mechanism, wherein the removable safetyclip comprises a first leg portion, a second leg portion, and a bridgingportion connecting the first and the second leg portions, and whereinthe first leg portion includes a first foot portion, wherein the secondleg portion includes a second foot portion, and wherein the first andthe second foot portions are configured to releasably engage one or moreapertures on an exterior surface of the sensor insertion assembly. 21.The sensor insertion assembly of claim 20, wherein the first and thesecond leg portions are biased in an inward direction.
 22. The sensorinsertion assembly of claim 20, wherein the mounting unit includes anadhesive bottom surface.
 23. The sensor insertion assembly of claim 20,wherein the mounting unit is configured to receive a sensor electronicsunit after the inserter housing is uncoupled from the mounting unit. 24.The sensor insertion assembly of claim 20, wherein the first and thesecond foot portions are biased in an inward direction.
 25. The sensorinsertion assembly of claim 20, wherein the actuator mechanism comprisesat least one depressible button.
 26. The sensor insertion assembly ofclaim 25, wherein the removable safety clip is further configured toprevent the at least one depressible button from being depressed. 27.The sensor insertion assembly of claim 20, wherein the removable safetyclip is configured to disengage from the sensor insertion assembly uponapplication of one or more forces to the first and the second legportions.
 28. The sensor insertion assembly of claim 20, wherein thefirst and the second foot portions are configured to disengage from theone or more apertures upon application of one or more forces to thefirst and the second leg portions.
 29. The sensor insertion assembly ofclaim 20, wherein the one or more forces comprises a squeezing force.30. The sensor insertion assembly of claim 20, wherein the at least aportion of the analyte sensor is disposed in a channel of the introducersharp while the drive spring is in a compressed state.
 31. The sensorinsertion assembly of claim 20, wherein the drive spring and theretraction spring comprise compression springs.
 32. The sensor insertionassembly of claim 20, wherein the drive spring and the retraction springare each in a compressed state prior to the actuation of the actuatormechanism.
 33. The sensor insertion assembly of claim 20, wherein theanalyte sensor is a glucose sensor.
 34. The sensor insertion assembly ofclaim 20, wherein the mounting unit includes an aperture through whichthe introducer sharp and the at least portion of the analyte sensor arepositioned under a skin layer upon release of the drive spring.
 35. Thesensor insertion assembly of claim 20, wherein the bridging portioncomprises a flexible plastic material.
 36. The sensor insertion assemblyof claim 20, wherein a diameter of the drive spring is greater than adiameter of the retraction spring.
 37. The sensor insertion assembly ofclaim 20, wherein the analyte sensor includes a distal portion and aproximal portion, the distal portion configured to be in fluid contactwith subcutaneous bodily fluid and having a width smaller than a widthof the proximal portion.